Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-25 @ 4:37 PM
Study NCT ID:
NCT02144402
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2014-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth of Healthy Term Infants Fed Formula Containing DHA-B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041943', 'term': 'Infant Formula'}], 'ancestors': [{'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D007225', 'term': 'Infant Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'adverse events', 'timeFrame': 'through day of life 120', 'description': 'AEs collected throughout the study'}], 'primaryOutcomes': [{'measure': 'weight gain (gm/day)', 'timeFrame': 'through day of life 120', 'description': 'gm/day -calculated from the weight measured at enrollment subtracted from the weight measured at DOL 120 visit, divided by the number of days between the actual visits.'}], 'secondaryOutcomes': [{'measure': 'length (cm)', 'timeFrame': 'through day of life 120', 'description': 'Length in cm'}, {'measure': 'head circumference (cm)', 'timeFrame': 'through day of life 120', 'description': 'head circumference (cm)'}, {'measure': 'fatty acid levels (wgt %)', 'timeFrame': 'at day of life 120', 'description': 'red blood cell (RBC) levels of omega-3 and omega-6 fatty acids (wgt %) in a sample subset'}, {'measure': 'Formula intake and tolerance', 'timeFrame': 'Day of life 30 and 120', 'description': 'assessed by analyzing three-day dietary intake and tolerance forms'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Growth', 'Tolerance', 'Infant Development']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine if the weight gain of healthy term infants fed a commercially available term infant formula supplemented with DHASCO® is similar to that of infants fed the same formula supplemented with a new product, DHASCO®-B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full term infant (gestational age 37-42 weeks)\n* birth weight \\> or equal to 2500 g\n* singleton infant \\< or equal to 14 days of age in good health\n* parent must be \\>21 years of age\n* parental consent\n\nExclusion Criteria:\n\n* congenital malformation or genetic disorder\n* metabolic anomalies\n* maternal infectious diseases, alcoholism, substance abuse\n* mothers with gestational diabetes\n* participation in another clinical study'}, 'identificationModule': {'nctId': 'NCT02144402', 'briefTitle': 'Growth of Healthy Term Infants Fed Formula Containing DHA-B', 'organization': {'class': 'INDUSTRY', 'fullName': 'DSM Nutritional Products, Inc.'}, 'orgStudyIdInfo': {'id': '2013-1069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'infant formula with DHASCO', 'description': 'standard infant formula with docosahexaenoic acid (DHA)', 'interventionNames': ['Other: infant formula with DHASCO']}, {'type': 'EXPERIMENTAL', 'label': 'infant formula with DHASCO-B', 'description': 'standard infant formula with DHA-B', 'interventionNames': ['Other: infant formula with DHASCO-B']}], 'interventions': [{'name': 'infant formula with DHASCO', 'type': 'OTHER', 'armGroupLabels': ['infant formula with DHASCO']}, {'name': 'infant formula with DHASCO-B', 'type': 'OTHER', 'armGroupLabels': ['infant formula with DHASCO-B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Claude Ashley, MD', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'JBRKIDS', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '06360', 'city': 'Norwich', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Norwich Pediatric', 'geoPoint': {'lat': 41.52426, 'lon': -72.07591}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Score Physician Alliance', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': 'Atlantic Clinical Research', 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '47630', 'city': 'Newburgh', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pedia Research', 'geoPoint': {'lat': 37.94449, 'lon': -87.40529}}, {'zip': '67205', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Heartland Research', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '02720', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Stephen Kasparian', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '68504', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'MCHRI', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '45414', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Pediatric Research', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DSM Nutritional Products, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Accelovance', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}